Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00594867
Eligibility Criteria:
Inclusion Criteria:
1. Be a cooperative, healthy male or female between the ages of 18-75 inclusive.
2. Have a physical examination which reveals no clinically significant abnormalities at the screening visit.
3. Have fewer than 6 gastric or duodenal erosions visible on nasal endoscopy at Visit 2.
4. If the subject is female and of childbearing potential, she has been using effective contraception since the last date of her menses, will continue to use effective contraception during the study period, is not breast-feeding or lactating at screening and has had a negative urine pregnancy test at screening. Women who have been post-menopausal for less than 2 years will also require a urine pregnancy test at screening.
5. Have provided written informed consent prior for admission to this study.
6. H. pylori negative serologic exam prior to baseline nasal EGD.
Exclusion Criteria:
1. Active GI disease (e.g. IBD), or a history of GI ulcers or bleeding
2. History of gastric or intestinal surgery
3. Use of ASA, NSAIDs, coxibs, or acetaminophen at any dose within 2 weeks prior to the randomization visit of the study.
4. Positive FOBT at baseline.
5. Use of over-the-counter or prescription: sucralfate, antacids, H2-receptor antagonists, misoprostol, or proton pump inhibitors 4 weeks prior to enrollment and/or during the study
6. A known allergy to the topical anesthetic, lidocaine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00594867
Study Brief:
Protocol Section:
NCT00594867